BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BINAXNOW COVID-19 AG SELF TEST 2CT

    MDR report key: 16899254 · Received May 9, 2023

    Report

    Report Number
    1221359-2023-01106
    Event Type
    Malfunction
    Date Received
    May 9, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 25, 2023
    Manufacturer
    ABBOTT DIAGNOSTICS SCARBOROUGH, INC.
    Product Code
    QKP
    UDI-DI
    00811877011408
    PMA / PMN Number
    EUA210264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    TESTING WAS PERFORMED AT ABBOTT DIAGNOSTICS SCARBOROUGH, INC. ON RETAINED KIT LOT 215578 WITH INTERNAL POSITIVE QUALITY CONTROL SAMPLES AND NEGATIVE QUALITY CONTROL SWABS. ALL TEST RESULTS WERE VALID AND PERFORMED AS EXPECTED. ADDITIONALLY, THE MANUFACTURING RECORDS AND QUALITY CONTROL RELEASE TESTING WAS REVIEWED FOR TEST KIT PART NUMBER 195-160 / LOT 215578 AND DEVICE PART NUMBER 195-430WL / LOT 213047. THE LOT MET THE REQUIRED RELEASE SPECIFICATIONS. A REVIEW OF THE COMPLAINTS REPORTED AS FALSE NEGATIVE PATIENT RESULTS (CONFIRMED AND UNCONFIRMED, CONFLICTING RESULTS) RELATED TO KIT LOT 215578 SHOWED THAT THE COMPLAINT RATE IS (B)(4)%. ABBOTT DIAGNOSTICS SCARBOROUGH, INC. WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE OF THE REPORTED ISSUE, HOWEVER IT COULD HAVE POSSIBLY BEEN RELATED TO ISSUES INCLUDING THE SELF-TEST USER PERFORMANCE, INTERPRETATION OF THE RESULT, OR THE SPECIFIC PATIENT SAMPLE. H3 OTHER TEXT : DEVICE DISCARDED, SINGLE USE.

    Additional Manufacturer Narrative · 0

    NEW INFORMATION WAS RECEIVED ON 03MAY2023, THE CONSUMER CONFIRMED THAT THEY PERFORMED EIGHT TESTS INSTEAD OF FOUR TESTS THAT INITIALLY REPORTED IN EVENT. THE EVENT DATE IS AN ESTIMATE. THE INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE PROVIDED AFTER COMPLETION. DEVICE DISCARDED, SINGLE USE.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED ON BEHALF OF HER DAUGHTER EIGHT (8) FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST ON DIFFERENT DATES IN APRIL. PER THE CONSUMER, HER DAUGHTER RECEIVED FOUR (8) NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST, AND A POSITIVE RESULT AT A DOCTOR OFFICE. THE PATIENT TOOK TYLENOL, AIRBORNE, ADVAIR, ELDERBERRY, AND SHE WAS IN ISOLATION. ADDITIONALLY, THE PATIENT WAS RECEIVED TWO COVID VACCINES SHOTS (PFIZER) IN LATE 2021, NO BOOSTER. THIS MFR. REPORT ADDRESSES TEST (7) SEVEN OF EIGHT (8) TESTS AND WAS TAKEN BETWEEN (B)(6) 2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Description of Event or Problem · 0

    THE CONSUMER REPORTED ON BEHALF OF HER DAUGHTER EIGHT (8) FALSE NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST ON DIFFERENT DATES IN (B)(6). PER THE CONSUMER, HER DAUGHTER RECEIVED FOUR (8) NEGATIVE RESULTS WITH BINAXNOW COVID-19 AG SELF-TEST, AND A POSITIVE RESULT AT A DOCTOR OFFICE. THE PATIENT TOOK TYLENOL, AIRBORNE, ADVAIR, ELDERBERRY, AND SHE WAS IN ISOLATION. ADDITIONALLY, THE PATIENT WAS RECEIVED TWO COVID VACCINES SHOTS (PFIZER) IN LATE 2021, NO BOOSTER. THIS MFR. REPORT ADDRESSES TEST (7) SEVEN OF EIGHT (8) TESTS AND WAS TAKEN BETWEEN (B)(6) 2023. NO ADDITIONAL PATIENT INFORMATION, INCLUDING TREATMENT AND OUTCOME, WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590525 BINAXNOW COVID-19 AG SELF TEST 2CT CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ABBOTT DIAGNOSTICS SCARBOROUGH, INC. 215578 00811877011408

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female